Completed

NCT Number: NCT04476498

Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy

The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.

Completed

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Key information

Conditions

Peristomal Infection Rate Postinterventional Bleeding Postinterventional Mortality Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

About this study

Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection rates are one of the most common early complications which are caused by bacterial transmission through the oropharyngeal passage of the tube and by bacterial translocation out of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and peristomal infection rates can be reduced significantly.

This randomised study wants to compare the peristomal infection rate of standard pull-PEGs and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical inflammation rates including erythema, exsudates, and induration, development of pus, or focal peritonitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 18 and over with an indication for a PEG-insertion

Exclusion criteria

ASA-classification >4
female patients who are pregnant or breast feeding
existing contraindications for a PEG-implantation

Treatment and study plan

Pull-PEG with Gastropexy

Procedure

Additionally to a conventional pull-PEG a gastropexy will be performed.

Primary outcomes

Peristomal infection rate

Time frame: 36 months

Peristomal infection rate will be compared after conventional pull-PEG and pull-PEG with gastropexy. Peristomal infection is detected classical inflammation parameters (erythema, indulation, exsudate, ulcer and bleeding).
Postinterventional bleeding

Time frame: 36 months

Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters
Postinterventional occurrence of fistulas

Time frame: 36 months

Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 20, 2020
Registry last updated: Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.